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Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00004923
First received: March 7, 2000
Last updated: August 21, 2009
Last verified: August 2009
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Drug: irinotecan hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Yale University:

Enrollment: 47
Study Start Date: April 1999
Study Completion Date: May 2006
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting toxicity of this regimen in these patients. III. Assess any antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven solid malignancy for which no effective therapy is currently available CNS metastases allowed if CNS disease is stable for at least 4 weeks following completion of surgery and/or radiotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: At least 3 months Life expectancy: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL SGOT and/or SGPT no greater than 1.5 times upper limit of normal (ULN) (no greater than 2.5 times ULN allowed if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN allowed if SGOT and/or SGPT no greater than ULN) Renal: Creatinine clearance at least 55 mL/min Other: HIV negative No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent medical condition that would preclude compliance with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy regimens containing topotecan, irinotecan, or docetaxel At least 4 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas, melphalan, or mitomycin) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior wide field radiotherapy No prior radiotherapy to greater than 20% of bone marrow Surgery: See Disease Characteristics Recovered from any prior surgery Other: No other concurrent investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004923

Locations
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Bennett Cancer Center
Stamford, Connecticut, United States, 06902
Sponsors and Collaborators
Yale University
Investigators
Study Chair: John R. Murren, MD Yale University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004923     History of Changes
Other Study ID Numbers: CDR0000067606, YALE-HIC-10023, NCI-G00-1700
Study First Received: March 7, 2000
Last Updated: August 21, 2009
Health Authority: United States: Federal Government

Keywords provided by Yale University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Docetaxel
Irinotecan
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014